(25 days)
Not Found
No
The description focuses solely on the physical design and function of an MRI coil for receiving RF signals, with no mention of software processing, algorithms, or AI/ML capabilities for image analysis or interpretation.
No.
The device is used to produce diagnostic images, not to treat conditions.
Yes
The device produces diagnostic images that are interpreted by a trained physician for diagnosis.
No
The device description clearly details physical components like flexible flaps, adjustable straps, rigid housing, foamed pads, PCBs, and cables, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The dS Small Extremity 16Ch 1.5T Coil is a component of an MRI system. Its function is to receive radio frequency signals from the body to produce diagnostic images. It does not analyze biological samples.
- Intended Use: The intended use is to produce diagnostic images of the extremities, which are then interpreted by a trained physician. This is a form of medical imaging, not in vitro testing.
Therefore, the device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The dS Small Extremity 16Ch 1.5T Coil is to be used in conjunction with a Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the extremities that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The proposed dS Small Extremity 16Ch 1.5T Coil is designed for use with Magnetic Resonance Imaging (MRI) systems. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei.
The proposed dS Small Extremity 16Ch 1.5T Coil is a volume phased array receive-only coil for high resolution diagnostic imaging of small extremities. The coil is made of two flexible flaps and adjustable straps for ease of workflow. The coil rigid housing is made with Lexan 925 material and the foamed pad is coated with Dartex Polyurethane; with dimensions to be 13.5"x10x9 inches to accommodate 16 Channel construction; the former using Kapton rigid-Flex PCB (loop elements) and FR-4 PCB (feedboard, interface boards), and urethane-jacketed cable to connect to MR system. The coil provides unilateral images (Left and Right) of the anatomy of interest.
The small extremity (Hand, Finger, Elbow) comfort pads are made of Urethane core with Polyvinyl Nitrile wrap, coated with Polyscan material; the Base Plate and Table Pads are also coated with Polyscan material.
Variations between the proposed dS Small Extremity 16Ch 1.5T Coil and the currently marketed and predicate device 1.5T and 3.0T-8Channel Small Extremity Coil include MR system compatibility and a 16-channel connection to the MRI system. Mechanical design changes include modifications to the connector to permit the 16-channel connection and the specified MR system compatibility. In addition, modifications to the overall dimensions improve workflow as well as meet customer requirements.
Proposed changes to the device
- Coil housing material changed from Lexan 950 to Lexan 925 for ease of availability with no impact to device safety and effectiveness
- Some of Coil pads coating changed to Polyscan coating for ease of availability with no ● impact to device safety or effectiveness.
- Channel count was increased from 8 channels to 16 channels to meet the customer/market needs with no impact on device to safety and effectiveness.
- . The overall coil dimensions were changed from 11.5" x 9.0" x 11.5"to 13.5" x 10.0" x 9.0" to accommodate more channels with no impact to device safety and effectiveness.
The proposed 1.5T 16 Ch Small Extremity Coil is designed to be used with the Philips 1.5T MRI Scanners with dStream capabilities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
extremities (Hand, Finger, Elbow)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench performance testing includes both non-clinical testing and clinical demonstrations of the representative anatomic region (extremity imaging) using FDA-cleared Philips 1.5T scanner. The non-clinical testing characterizes the Signal-to-Noise Ratio (SNR), Image Uniformity and special purpose of the RF receive-only coil. The clinical demonstration DICOM images were reviewed by a clinical radiologist to confirm the image quality is adequate. The images and supporting attestation statements by the radiologist are provided in Appendix 5, Clinical Evaluation.
Non-clinical verification and validation test results demonstrate that the proposed dS Small Extremity 16Ch 1.5T Coil
- Complies with the device specifications, identified international and FDA-recognized . consensus standards, and device specific guidance document entitled "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices"
- . Meets the acceptance criteria and is adequate for its intended use.
The proposed dS Small Extremity 16Ch 1.5T Coil does not require clinical study since substantial equivalence to the predicate device was demonstrated with the following attributes:
- Design features: ●
- Indication for use; ●
- Technological characteristic;
- Non-clinical performance testing; and ●
- Safety and effectiveness ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November7, 2016
Invivo Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K162863
Trade/Device Name: dS Small Extremity 16Ch 1.5T Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 11, 2016 Received: October 13, 2016
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name dS Small Extremity 16Ch 1.5T Coil
Indications for Use (Describe)
The dS Small Extremity 16Ch 1.5T Coil is to be used in conjunction with a Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the extremities that can be interpreted by a trained physician.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitted by: | Invivo Corporation
3545 SW 47th Ave
Gainesville, FL 32608 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Name | Invivo Corporation |
| Establishment
Registration Number: | 1056069 |
| Contact Person: | Ken Revennaugh
Title: Director of Quality and Regulatory
Invivo Corporation
3545 SW 47th Ave
Gainesville, FL 32608
Phone: (352) 384-8590
E-mail: ken.revennaugh@philips.com |
| Date Prepared: | November 04, 2016 |
| Trade Name: | dS Small Extremity 16Ch 1.5T Coil |
| Common Name: | Magnetic resonance diagnostic device |
| Classification Name: | Coil, Magnetic Resonance, Specialty |
| Classification
Regulation Number: | 892.1000 |
| Classification: | Class II |
| Classification Panel: | Radiology |
| Product code: | MOS |
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Device Description:
The proposed dS Small Extremity 16Ch 1.5T Coil is designed for use with Magnetic Resonance Imaging (MRI) systems. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei.
The proposed dS Small Extremity 16Ch 1.5T Coil is a volume phased array receive-only coil for high resolution diagnostic imaging of small extremities. The coil is made of two flexible flaps and adjustable straps for ease of workflow. The coil rigid housing is made with Lexan 925 material and the foamed pad is coated with Dartex Polyurethane; with dimensions to be 13.5"x10x9 inches to accommodate 16 Channel construction; the former using Kapton rigid-Flex PCB (loop elements) and FR-4 PCB (feedboard, interface boards), and urethane-jacketed cable to connect to MR system. The coil provides unilateral images (Left and Right) of the anatomy of interest.
The small extremity (Hand, Finger, Elbow) comfort pads are made of Urethane core with Polyvinyl Nitrile wrap, coated with Polyscan material; the Base Plate and Table Pads are also coated with Polyscan material.
Variations between the proposed dS Small Extremity 16Ch 1.5T Coil and the currently marketed and predicate device 1.5T and 3.0T-8Channel Small Extremity Coil include MR system compatibility and a 16-channel connection to the MRI system. Mechanical design changes include modifications to the connector to permit the 16-channel connection and the specified MR system compatibility. In addition, modifications to the overall dimensions improve workflow as well as meet customer requirements.
Proposed changes to the device
- Coil housing material changed from Lexan 950 to Lexan 925 for ease of availability with no impact to device safety and effectiveness
- Some of Coil pads coating changed to Polyscan coating for ease of availability with no ● impact to device safety or effectiveness.
- Channel count was increased from 8 channels to 16 channels to meet the customer/market needs with no impact on device to safety and effectiveness.
- . The overall coil dimensions were changed from 11.5" x 9.0" x 11.5"to 13.5" x 10.0" x 9.0" to accommodate more channels with no impact to device safety and effectiveness.
The proposed 1.5T 16 Ch Small Extremity Coil is designed to be used with the Philips 1.5T MRI Scanners with dStream capabilities.
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Image /page/5/Picture/0 description: The image shows the logo for Invivo. The logo consists of a circle with the letter "I" inside of it, followed by the word "Invivo" in a sans-serif font. The logo is purple in color. There is a trademark symbol to the right of the word "Invivo".
Photograph:
Image /page/5/Picture/2 description: The image shows a medical device, possibly an MRI coil, designed to fit around a limb or body part. It is light beige in color with white straps and black buckles securing the device. The device has a cylindrical shape with an opening in the center, suggesting it is meant to encircle a body part for imaging purposes. There are also cylindrical attachments on either side of the main device, connected by cables, which likely serve as connectors to the MRI machine.
Patient Safety
Description of design that assures that the coil will remain decoupled:
Each coil incorporates a redundant decoupling strategy. A fast recovery back-to-back PIN diode pair is placed in series with an inductor across a capacitor. The inductor is tuned to shift the resonant frequency of the coil. There is also a fuse in series with the loop that would break loop resonance in event of high currents. During system transmitted pulses, a D.C. voltage is supplied to each channel of the array by the MRI system. This voltage drives the PIN diodes or Dual diodes conduct, thus engaging the decoupling circuit. The coil resonant frequency then shifts away from the system resonant frequency. The coil therefore becomes a very poor receiver of RF energy at the system operating frequency during the transmit pulses.
In the event that the coil is placed in the magnet and the operator neglects to plug in the coil, the PIN diodes or Dual diodes function as a passive decoupling system. In this case, the decoupling takes place without the need for the voltage supplied by the MRI system.
Description of electrical isolation of the patient from the surface coil electrical conductors:
The electrical conductors are etched on FR4 printed circuit board. The circuit boards are encased in plastic housing. The plastic housing wall and/or foam is a minimum of .10' thick. At no time is it possible for the coil conductors to touch the patient. The cable exits the coil superior to the patient's head to connect to the MRI system connector. The cables are of such a length to reach the MRI system coil part by running the cables away from patient. The cable is
6
designed such that the cable is difficult to make the loop shape during use. The cables have insulation jackets and additional padding that increase separation of the cable if it did somehow become looped.
Indications for Use:
The dS Small Extremity 16Ch 1.5T Coil is to be used in conjunction with a Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the extremities that can be interpreted by a trained physician.
Predicate Device Information:
| Predicate Device Name | Predicate 510(k)
Submission Reference |
|---------------------------------------------|------------------------------------------|
| 1.5T and 3.0T-8Channel Small Extremity Coil | K091902 |
Safety and Effectiveness:
The proposed dS Small Extremity 16Ch 1.5T Coil labeling contain instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via Invivo Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via the product development process, verification and validation testing and safety features provided by the MRI Scanners.
Technological Characteristics:
The technological characteristics of the proposed dS Small Extremity 16Ch 1.5T Coil is exactly the same as the currently marketed and predicate device 1.5T and 3.0T-8Channel Small Extremity Coil.
The technological characteristic of a receive-only radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest. This technological characteristic of the proposed dS Small Extremity 16Ch 1.5T Coil has not changed as compared to the technological characteristic of the currently marketed and predicate device 1.5T and 3.0T-8Channel Small Extremity Coil.
Based on the information provided above, the proposed dS Small Extremity 16Ch 1.5T Coil is considered substantially equivalent to the currently marketed and predicate device 1.5T and 3.0T-8Channel Small Extremity Coil (K091902) in terms of technological characteristics.
The proposed dS Small Extremity 16Ch 1.5T Coil utilizes the same technological characteristic as the predicate 1.5T and 3.0T-8Channel Small Extremity Coil. Both have similar design,
7
Image /page/7/Picture/0 description: The image shows the logo for Invivo. The logo consists of a circle with a line through it and the letter "I" inside of it. To the right of the circle is the word "Invivo" in a sans-serif font. The color of the logo is purple.
intended use, patient safety features, housing materials, overall dimensions, and operating principals; and substantially equivalent in their performance and effectiveness for their intended uses.
Following is the comparison of technological characteristics between the currently marketed and predicate device 1.5T and 3.0T-8Channel Small Extremity Coil and proposed dS Small Extremity 16Ch 1.5T Coil:
| Table-01 | |||
|---|---|---|---|
| Comparison of the Technological Characteristics of the Predicate Device and the Proposed Device | |||
| Device Features | Predicate Device | ||
| K091902 | |||
| 1.5T and 3.0T-8Channel | |||
| Small Extremity Coil | Proposed Device | ||
| dS Small Extremity 16Ch | |||
| 1.5T Coil | Comments | ||
| Indications for Use | The coil is indicated for use | ||
| on the order of a physician, | |||
| in conjunction with an MR | |||
| scanner as an accessory to | |||
| produce images of the | |||
| upper and lower | |||
| extremities, as an aid to | |||
| diagnosis. | The ds Small Extremity | ||
| 16 Ch 1.5T coil is to be | |||
| used in conjunction with | |||
| a Philips 1.5T Magnetic | |||
| Resonance Scanner to | |||
| produce diagnostic | |||
| images of the extremities | |||
| that can be interpreted | |||
| by a trained physician. | Addition of proposed | ||
| coil name to the | |||
| indication for use | |||
| statement does not | |||
| affect its intent use as | |||
| well as impact | |||
| device's safety and | |||
| effectiveness. | |||
| Coil Dimensions | |||
| Length x Width x | |||
| Height | 11.5 x 9 x 11.5 inches | 13.5 x 10.0 x 9.0 inches | The change in |
| dimensions is to | |||
| accommodate more | |||
| channels. No impact to | |||
| device safety and | |||
| effectiveness. | |||
| Coil Frequency | 63.87 MHz | Identical | No Change |
| Coil Design | Receive-only, Phased Array | Identical | No Change |
| Magnetic Field | |||
| Orientation (B0) | Horizontal | Identical | No Change |
| Coil Geometry | |||
| Housing Design | One piece housing | Identical | No Change |
| Housing Thickness | .10 inch insulation | ||
| minimum | .07 inch insulation | ||
| minimum | The change in | ||
| insulation thickness at | |||
| discrete locations has | |||
| no impact on devices | |||
| functionality, safety | |||
| and effectiveness. | |||
| Decoupling Method | LC Tank Circuit | Identical | No Change |
| Table-01 | |||
| Comparison of the Technological Characteristics of the Predicate Device and the Proposed Device | |||
| Device Features | Predicate Device | ||
| K091902 | |||
| 1.5T and 3.0T-8Channel | |||
| Small Extremity Coil | Proposed Device | ||
| dS Small Extremity 16Ch | |||
| 1.5T Coil | Comments | ||
| Number of Channels/ | |||
| Preamplifiers | 8 channels / 8 preamplifiers | 16 channels / 16 | |
| preamplifiers | The number of | ||
| channels was | |||
| increased to meet the | |||
| customer and market | |||
| needs. No impact to | |||
| device safety and | |||
| effectiveness. | |||
| Housing Material | Lexan 950 | Lexan 925 | Both are similar |
| materials and have | |||
| been used in current | |||
| products. No impact to | |||
| device safety and | |||
| effectiveness. | |||
| Coil Inner Flap | Polyurethane-coated | ||
| EVA foam | EVA Foam with | ||
| Dartex Polyurethane | |||
| Coating | Both are similar | ||
| materials and have | |||
| been used in current | |||
| products. No impact to | |||
| device safety and | |||
| effectiveness. | |||
| Small Extremities | |||
| (Hand, Finger, Elbow) | |||
| Comfort Pads | N/A | Urethane core with | |
| Polyvinyl Nitrile wrap; | |||
| Polyscan Coating | Both are similar | ||
| materials and have | |||
| been used in current | |||
| products. No impact to | |||
| device safety and | |||
| effectiveness. | |||
| Base plate and table | |||
| Pads | Polyurethane-coated | ||
| EVA foam | EVA Foam with | ||
| Polyscan Coating | Both are similar | ||
| materials and have | |||
| been used in current | |||
| products. No impact | |||
| to device safety and | |||
| effectiveness. | |||
| System Connector / | |||
| Compatibility | ODU CDAS Connector for | ||
| Philips Scanner | Identical | No Change |
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Image /page/9/Picture/0 description: The image shows the Invivo logo. The logo consists of a circle with a break in the upper right quadrant and the letter "I" inside. To the right of the circle is the word "Invivo" in a sans-serif font. The logo is purple.
Non-Clinical Performance Testing Information:
The proposed dS Small Extremity 16Ch 1.5T Coil complies with the following international and FDA-recognized consensus standards:
- IEC 60601-1, 3rd edition ●
- IEC 60601-2-33, 3rd edition ●
- ISO 14971, 2nd edition .
- ISO 10993-1, 2nd edition ●
- . Device specific draft guidance document, entitled "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - July 14, 2015"
Bench performance testing includes both non-clinical testing and clinical demonstrations of the representative anatomic region (extremity imaging) using FDA-cleared Philips 1.5T scanner. The non-clinical testing characterizes the Signal-to-Noise Ratio (SNR), Image Uniformity and special purpose of the RF receive-only coil. The clinical demonstration DICOM images were reviewed by a clinical radiologist to confirm the image quality is adequate. The images and supporting attestation statements by the radiologist are provided in Appendix 5, Clinical Evaluation.
Non-clinical verification and validation test results demonstrate that the proposed dS Small Extremity 16Ch 1.5T Coil
- Complies with the device specifications, identified international and FDA-recognized . consensus standards, and device specific guidance document entitled "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices"
- . Meets the acceptance criteria and is adequate for its intended use.
Therefore, the proposed dS Small Extremity 16Ch 1.5T Coil is substantially equivalent to the currently marketed and predicate device 1.5T and 3.0T-8Channel Small Extremity Coil (K091902) in terms of safety and effectiveness.
Summary of Clinical Data:
The proposed dS Small Extremity 16Ch 1.5T Coil does not require clinical study since substantial equivalence to the predicate device was demonstrated with the following attributes:
- Design features: ●
- Indication for use; ●
- Technological characteristic;
- Non-clinical performance testing; and ●
- Safety and effectiveness ●
10
Conclusion:
The proposed dS Small Extremity 16Ch 1.5T Coil is substantially equivalent to the currently marketed and predicate device 1.5T and 3.0T-8Channel Small Extremity Coil (K091902) in terms of design features, principals of operation, technological characteristic, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the device specifications, and requirements specified in the international and FDA-recognized consensus standards. The results of these tests demonstrate that proposed dS Small Extremity 16Ch 1.5T Coil meets the acceptance criteria and is adequate for the established intended use.
The results of both non-clinical and device performance tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device.